tbuckley/cabot-search huggingface dataset:
Transcatheter arterial chemoembolization using CalliSpheres beads loaded with arsenic trioxide for unresectable large or huge hepatocellular carcinoma: A prospective study.
Authors: Xuhuan Duan, Hao Li, Pengfei Chen, Tao Sun, Donglin Kuang, Huibin Lu, Bingbing Qiao, Zhengjun Fan, Jianzhuang Ren, Xinwei Han
Journal: Journal of Clinical Oncology (2023)

e16204 Background: To determine the safety and efficacy of transcatheter arterial chemoembolization with CalliSpheres beads loaded with arsenic trioxide (CBATO-TACE) in the first-line treatment of patients with large (5 cm ≤ maximum diameter＜10 cm) or huge (maximum diameter ≥10 cm) hepatocellular carcinoma (HCC). Methods: Patients were randomly allocated to the CBATO-TACE group and the cTACE group. The primary endpoint was progression-free survival (PFS). The secondary endpoint was overall survival (OS), treatment response, and treatment- related adverse events (TRAEs). The extrahepatic collateral arteries, liver function, and liver fibrosis after the first TACE were also evaluated. Results: From September 2018 to September 2020, a total of 207 patients underwent TACE were consecutively enrolled in this study. The median PFS was 9.5 months (range: 8.0-11.0) in the CBATO group, which was significantly longer than that in the cTACE group (6.0 months, range: 4.0-6.0) ( P&lt; 0.0001). Patients in the CBATO group had a median OS of 22 months (range: 20.0-27.0) compared with 16 months (range:15.0-20.0）in the cTACE group ( P= 0.0084). The most common TRAEs were fever ( P= 0.043), nausea and vomiting ( P= 0.002), which were more observed in the cTACE group. In addition, the progressive disease time, pulmonary metastasis rate ( P= 0.01), the mean number of EHC arteries ( P= 0.01) and average number of TACE sessions ( P= 0.025) were significantly decreased in the CBATO group. Conclusions: CBATO-TACE achieved better therapeutic outcomes and similar safety profile compared to cTACE in large or huge HCC patients. Furthermore, CBATO-TACE was able to reduce extrahepatic collateral arteries production and extrahepatic lung metastasis. Clinical trial information: ChiCTR1800018418 .
Nationwide implementation of best practices in pancreatic cancer care (PACAP-1): Stepped-wedge cluster randomized trial.
Authors: Tara Mackay, Anouk EJ Latenstein, Simone Augustinus, Lydia G. van der Geest, Auke Bogte, Bert A. Bonsing, Hendrik Bos, Koop Bosscha, Lodewijk Brosens, Geert A. Cirkel, Lieke Hol, Olivier R.C. Busch, Geert-Jan Creemers, Wouter L. Curvers, Sarah Derks, Jeanin E. van Hooft, Casper H.J. Van Eijck, Johanna Wilmink, Hanneke W.M. Van Laarhoven, Marc G. Besselink
Journal: Journal of Clinical Oncology (2023)

4152 Background: Implementation of new treatment strategies in cancer care is often inadequate and slow. We aimed to implement best practices in pancreatic cancer care using a nationwide stepped wedge design and assess the impact on overall survival. Methods: Nationwide multicenter stepped-wedge cluster randomized controlled trial comparing implementation of best practices with usual care (May 22, 2018 – May 29, 2020). Best practices included adequate use of perioperative and palliative chemotherapy, pancreatic enzyme replacement therapy (PERT), and metal biliary stents. The 6-week implementation period in all 17 Dutch pancreatic centers and their regional referral networks included monitoring, return visits, and provider feedback in combination with education and reminders. Primary outcome was one-year overall survival for all disease stages and secondary outcomes included guideline compliance and quality of life. Results: Overall, 5580 patients diagnosed with pancreatic cancer were included; 2939 after implementation of best practices versus 2641 before. One-year survival did not differ among the groups (HR 0.98, 95 CI 0.88-1.08). Overall use of perioperative chemotherapy (neoadjuvant and adjuvant) did not significantly differ, but use of palliative chemotherapy significantly increased (23.9% to 30.3%, OR 1.38, 95 CI 1.10-1.74). Also the use of PERT (34.2% to 45.2%, OR 1.64, 95 CI 1.28-2.11); and metal biliary stents (74.1.% to 83.3%, OR 1.78, 95 CI 1.13-2.08) significantly increased. The Global Health Score did not differ (AUC 43.8 to 42.7, median difference -1.12, 95 CI -3.13-0.80, n=655). Conclusions: This nationwide population-based trial to enhance implementation of best practices in pancreatic cancer care showed successful implementation of most best practices, but no increase in one-year survival and quality of life. Clinical trial information: NCT03513705 .
Racial disparities in the outcomes of allogeneic bone marrow transplant: A 5-year nationwide inpatient study.
Authors: Sindhu Vikash, Syeda Ashna Fatima Kamal, Fnu Vikash, Ansh Mehta, Leonidas Palaiodimos, Rama Al Hamed, Abdul-Hamid Bazarbachi, Rahul Kumar Thakur, Nishi Shah, Aditi Shastri, Ulrich G Steidl, Amit Verma, Alejandro R. Sica
Journal: Journal of Clinical Oncology (2023)

e19060 Background: Allogeneic bone marrow transplantation (ABMT) is a life-saving procedure in hematological malignancies and bone marrow failure disorders. Despite advances in the field, literature proposes racial disparities in the outcomes of ABMT. This study aims to investigate this difference among distinct racial cohorts. Methods: We identified patients who underwent ABMT for malignant and nonmalignant hematologic diseases from 2016-2020 using the nationwide inpatient sample (NIS) database. We compared the racial differences in outcomes during the hospitalization, including immunologic and hematologic complications, associated infections, length of stay, and mortality rate. Baseline characteristics were compared using a T-test and Chi-Square. Multivariate regression analysis was applied to estimate differences in outcomes. We used STATA Version 17.0 Software for data analysis. The p-value was set at p &lt; 0.05 for statistical significance. Results: A retrospective study was conducted on a cohort of 14,599 adults who underwent ABMT. Out of which 30% (4,379) developed complications. The mean age for ABMT was 54, and the average length of stay was 29 days. In this cohort, 79.5% (11,325) were whites, 4.2% (610) were blacks, 8.3% (1,185) were Hispanics, and 7.8% (1,125) were others. When comparing the outcomes among racial groups, invasive fungal infections 15.5% (95), mucositis 36% (220), septic shock 9% (55), and respiratory failure 14.7% (90) were more common in blacks (p &lt; 0.05). Neutropenia 41.3% (490) and cytomegalovirus (CMV) infection 12.2% (145) were more common in Hispanics (p &lt; 0.05). However, no significant difference was noted in immunologic complications (graft versus host disease (GVHD), bone marrow rejection (BMR), bone marrow failure (BMF)), pancytopenia, clostridium difficile infection (CDI), and mortality (p &lt; 0.05). Conclusions: Our study shows that blacks had a higher prevalence of invasive fungal infections, mucositis, septic shock, and respiratory failure, while Hispanics reported a higher prevalence of neutropenia and CMV infection. However, no significant differences were noted in GVHD, BMR, BMF, pancytopenia, CDI, and mortality rates. Therefore, it can be concluded that while there are some differences in post-ABMT complications among racial groups, overall, the rates of major complications and mortality do not significantly differ.
Circulating tumor DNA detection as a prognostic tool in patients with localized colon cancer: A systematic review and meta-analysis.
Authors: Quan Do, Vatsala Katiyar, Meghan Malloy, Vivek R. Sharma
Journal: Journal of Clinical Oncology (2023)

e15629 Background: Current modalities for postoperative risk stratification in localized colon cancer are still suboptimal in guiding adjuvant chemotherapy (ACT) administration. In recent years, circulating tumor DNA (ctDNA) has emerged as a novel biomarker to identify patients at high-risk for recurrence following R0 tumor resection. In this meta-analysis, we aimed to assess the prognostic value of ctDNA detection on postoperative recurrence risk that in the future, with further study, may help guide ACT treatment. Methods: Electronic databases Pubmed, Google Scholar, and Embase were searched up to 31 January 2023. Patient data were extracted using the following inclusion criteria: stage I to III colon cancers, R0 resection, sufficient ctDNA data following surgery, and no other concurrent malignancy. Pooled relative risk (RR) and 95% confidence interval (CI) were estimated to assess ctDNA positivity on the risk of recurrence in patients having surgery only, patients having surgery followed by ACT, and all patients combined. Random effects model was implemented to account for inter-study variation. Study heterogeneity was detected using χ 2 test and I 2 coefficient, with I 2 more than 50% indicating significant heterogeneity. All analyses were completed using RevMan 5, with p &lt; 0.05 being statistically significance. Results: Fifteen studies with a total of 3411 patients (64.4±10.7 years old) were evaluated. In patients undergoing surgery only without ACT treatment, postoperative ctDNA-positive patients were at higher risk of recurrence compared to those with negative ctDNA (RR = 7.73, 95% CI: 5.73-10.42, p &lt; 0.01, I 2 = 0%). In patients having surgery followed by ACT, postoperative/pre-ACT ctDNA-positive patients were at higher risk of recurrence compared to ctDNA-negative ones (RR = 5.25, 95% CI: 3.67-7.50, p &lt; 0.01, I 2 = 19%); post-ACT ctDNA-positive patients were also at higher risk of recurrence (RR = 6.34, 95% CI: 4.12-9.78, p &lt; 0.01, I 2 = 29%). When combining the two populations (surgery only and surgery followed by ACT), postoperative ctDNA-positive patients again have higher risk of recurrence (RR = 3.86, 95% CI: 2.63-5.67, p &lt; 0.01, I 2 = 87%); after completing all treatments, ctDNA-positive patients continue to have higher risk of recurrence (RR = 7.02, 95% CI: 3.40-14.51, p &lt; 0.01, I 2 = 94%). Conclusions: This meta-analysis shows that the presence of ctDNA post-surgery correlates with higher risk of disease recurrence. In localized colon cancers, ctDNA detection can be a valuable tool to identify high-risk patients who, regardless of pathologic stage, may be the most likely to benefit from ACT treatment. Additionally, patients with persistently positive ctDNA after completing ACT are at very high risk for recurrence and should require closer follow-up than current guidelines, along with consideration of enrollment in clinical trials of newer treatment strategies.
Clinical efficacy and safety of immune checkpoint inhibitor in combination with regorafenib therapy as second⁃line regimen for patients with unresectable hepatocellular carcinoma.
Authors: Jinpeng Li, Yuntao Jia, Jinlong Song
Journal: Journal of Clinical Oncology (2023)

e16105 Background: Combined systemic and local therapy is a promising treatment strategy for patients with advanced hepatocellular carcinoma (HCC). Transarterial chemoembolization (TACE), tyrosine kinase inhibitors (TKI) and PD-1 antibodies are all recommended for patients with unresectable HCC (uHCC). This study was aimed to evaluate the efficacy and safety of TACE combined with TKIs and camrelizumab in the treatment of uHCC. Methods: In this multicenter, single-arm phase II trial (ChiCTR2000039508), patients with intermediate-stage uHCC who had a Child-Pugh score ≤ 7 and had not received prior systemic anti-cancer treatment would receive treatment with TACE followed by immunotherapy with camrelizumab 200 mg every 3 weeks plus a TKI agent selected from lenvatinib (12 mg/day for bodyweight ≥60 kg or 8 mg/day for bodyweight &lt;60 kg), sorafenib 400 mg bid or donafenib 200 mg bid until intolerable toxicity or disease progression. During the study treatment, patients assessed as eligible for resection would undergo surgery. The primary endpoint was objective response rate (ORR) per modified RECIST. Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), duration of response (DOR) and overall survival (OS). Results: From September 2020 to November 2021, 87 patients (81 men and 6 women; median age, 56 years) were enrolled. Among them, 43 (49.4%) patients had extrahepatic metastases, and 65 (74.7%) patients had HBV infection. As of September 28, 2022, the median duration of follow-up was 13.6 (0.83-24.9) months. A total of 34 patients (39.1%) died, and the median OS was not reached. The median PFS was 10.5 months (95% CI: 7.8-13.1). The ORR rate was 71.3% (62/87), and the DCR rate was 89.7% (78/87) per mRECIST. According to RECIST version 1.1, the ORR rate was 35.6% (31/87), and the DCR rate was 87.4% (76/87). The ORR and PFS showed consistent benefits in subgroups based on ECOG score, HBV infection, baseline alpha-fetoprotein level, combined TKI, and the number of TACE treatments. Ten patients (11.5%) successfully underwent conversion therapy and all achieved R0 resection. Two patients achieved a complete pathological response (pCR) and four achieved a major pathological response (MPR). The most common AEs were hypoproteinemia (92%), elevated lactate dehydrogenase (80.5%), elevated glutamic oxaloacetic transaminase (79.3%), elevated bilirubin (78.2%), abdominal pain (62.1%), nausea (33.3%), and RCCEP (26.4%). The incidence of grade 3-4 adverse reactions was 67.8%, and no treatment-related deaths occurred. Conclusions: TACE combined with TKI and camrelizumab showed promising clinical benefits. It can effectively control tumor progression and provide opportunities for resection with acceptable safety, which will bring great benefits to uHCC.
Economic evaluation for the US of durvalumab plus gemcitabine and cisplatin (DGC) in advanced biliary tract cancer (BTC).
Authors: Osama Aqel, Yunrong Shen, Ibrahim Alfayoumi, Ivo Abraham
Journal: Journal of Clinical Oncology (2023)

4081 Background: BTCs are a group of relatively rare malignancies comprised of intrahepatic cholangiocarcinoma (CCA), extrahepatic CCA, and gallbladder cancer. The first-line standard of care of gemcitabine and cisplatin (GC) has remained unchanged for the past decade, highlighting the need for novel therapies. The TOPAZ-1 trial demonstrated improved progression-free (PFS) and overall survival (OS) with durvalumab added to GC. This trial-based economic evaluation estimated the cost-effectiveness/utility of DGC versus GC from a US payer perspective. Methods: A three state partitioned survival model (Progression-free, Progressed, Death) was developed to compare costs and overall survival outcomes associated with both treatments. PFS and OS curves were digitized, and parametric functions fitted. A 5-year time horizon with a 3% discount rate/year was considered. Costs of treatment (average sales price), administration, and monitoring parameters were sourced from Centers for Medicare &amp; Medicaid Services databases; costs of adverse event management (grade 3/4 with rate ≥ 5%) were sourced from prior BTC economic evaluations. Life years (LY), quality adjusted life years (QALY), incremental cost-effectiveness and utility ratios (ICER/ICUR) were estimated in a base case (BCA) and probabilistic sensitivity analyses (PSA). A cost-effectiveness acceptability curve (CEAC) was plotted to determine the probability of either treatment being cost-effective over the other at different willingness to pay (WTP) thresholds. Results: Exponential regression was used to extrapolate DGC and GC survival curves. As shown in the table, the BCA (PSA) shows an incremental cost of DGC over GC of 131,350 (131,212), incremental LY of 0.38 (0.38), and incremental QALY of 0.26 (0.28). The BCA and (PSA) ICERs reveal an additional 345,658 (345,295) per LY gained (g) and an additional 505,192 (468,614) per QALYg. The CEAC curve shows that DGC treatment has a 50% probability of being cost-effective at a WTP threshold value of 525,000 and 100% probability at a threshold of 1,375,000 or above. Conclusions: This economic evaluation demonstrates that, in the setting of advanced BTC, DGC is associated with a slight improvement in LY and QALY, yet at a marked incremental cost, requiring a very high WTP threshold. [Table: see text]
Treatment adherence and clinical outcomes of osimertinib (Osi) among ethnic-minority patients (pts) with EGFR-mutated NSCLC.
Authors: Matthew Lee, Emily Miao, Chenxin Zhang, Xiaonan Xue, Steven Tuckman, Balazs Halmos, Haiying Cheng
Journal: Journal of Clinical Oncology (2023)

e18536 Background: Osimertinib (Osi) is widely used in the management of patients with EGFR-mutated NSCLC but there is limited data on the treatment adherence and clinical outcome of Osi in ethnic minorities. This study aims to evaluate race/ethnicity, adherence and other demographic, socioeconomic and clinical factors of patients with NSCLC treated with Osi. Methods: A retrospective cohort study of a total of 102 patients with EGFR mutated NSCLC that were prescribed Osi from 1/1/16-12/31/22 with 46 patients within Montefiore’s own specialty pharmacy system with updated claims data. Adherence was measured using two methods with medication possession ratio (MPR) and proportion of days covered (PDC). Primary endpoint was overall survival (OS) along with secondary endpoints of progression-free survival (PFS) and treatment duration from the start of Osi, compared minority vs non-minority using log-rank testing and survival analysis with cox proportional models. Results: A median follow-up time of 10.5 months (mons), median age of 69 years old and 34.8% self-reported as Non-Hispanic Black (NHB), 45.6% as Hispanic (H), 10.9% as non-Hispanic White (NHW) and 8.7% non-Hispanic Asian. Treatment adherence did not differ between Blacks vs non-Blacks or Hispanics vs non-Hispanics using both MPR or PDC. The median out of pocket cost for our pts after financial assistance and insurance was around $80 (USD). Compared to non-Hispanics, Hispanics had similar OS, PFS and treatment duration. However, compared with Non-Blacks, Blacks had inferior PFS (p=0.021) and borderline significance of worse OS (p=0.052) and shorter duration of Osi (p=0.068). Further results are summarized in the table. Conclusions: Our study demonstrates that treatment adherence did not differ among minority vs. non-minority patients. However, unlike Hispanics who had similar survival to non-Hispanics, Blacks had inferior PFS, OS and shorter duration of Osi compared to Non-Blacks. This warrants further research on the underlying mechanisms to help improve patient care and outcome while undergoing Osi treatment especially in Black pts. [Table: see text]
Clinical outcomes of patients with newly diagnosed acute myeloid leukemia receiving treatment in a safety-net hospital system.
Authors: Jason Lu, Preeya Bhakta, Curtis Andrew Lachowiez, Effie Apostolidou
Journal: Journal of Clinical Oncology (2023)

7035 Background: Standard induction therapy for acute myeloid leukemia (AML) results in 5-year overall survival (OS) rates of 30-45%. Further risk stratification and novel therapeutic options have improved 5-year OS rates to 75-80% in certain subgroups. Despite these advances, many patients lack proper socioeconomic resources, leading to limited access to new therapies, clinical trials, and hematopoietic cell transplantation (HCT), which remains the only curative therapy for AML. Many of these patients receive care within publicly funded ‘safety net’ institutions designed to serve all individuals, regardless of ability to pay, insurance status, or immigration status. Outcomes of historically underserved patients with AML treated within a large county hospital system remain unknown. Methods: This retrospective cohort analysis evaluated clinical outcomes of patients aged ≥18 years with newly diagnosed AML (ND-AML) treated in the Harris County Health System, Houston, TX, from January 2005 to July 2019. Results: One hundred ninety-two patients with ND-AML were included (de novo AML [n = 140], secondary AML [n = 45], and therapy-related AML [n = 7]). Median age was 52 years (range: 19-89) at diagnosis, and 102 (52.3%) were male. Most patients identified as Hispanic (n = 110). Sixty-two percent of patients were uninsured or indigent, receiving care under the county’s financial assistance programs. The majority had adverse risk 84 (44.3%), while 78 were intermediate (40.6%), and 26 favorable risk (13.5%). Standard induction therapy was administered in 172 (88%) of patients. Cytarabine and Anthracycline (7+3) based regimens were most commonly used (72.8%). 192 patients were evaluable for response. 139 (72.4%) achieved composite complete remission (CR/CRi) and 41 (21.4%) had primary refractory disease. For those who achieved CR after first or second induction, the median duration of CR was 16.7 months. with 25 (13.7%) ultimately receiving HCT. Common reasons for not receiving HCT included lack of insurance (19.2%) or non-citizen status (23.1%) (n = 77). 82 of the 139 patients who achieved CR relapsed. After a median follow up of 16 months, five-year OS rates were 20.7% from our entire cohort of patients. Conclusions: In this cohort of patients treated in a safety-net system, median OS and EFS were lower than reported outcomes in the past decade. In addition, only 13.7% received HCT, one of the only curative treatments for AML. Some barriers included inability to refer to transplant center due to lack of financial support or immigration status. Addressing socioeconomic and institutional barriers to AML therapy and HCT will advance care for disadvantaged patients, thereby improving outcomes of patients AML.
Locoregional plus systemic therapy for unresectable intrahepatic cholangiocarcinoma: A systematic review and meta-analysis.
Authors: Zhenkang Qiu, Mengqi Zhang, Wensheng Qiu, Song Wang
Journal: Journal of Clinical Oncology (2023)

e16157 Background: The outcome of systemic therapy (ST) for unresectable intrahepatic cholangiocarcinoma (iCCA) is poor. This study aims to further evaluate the efficacy and safety of locoregional plus systemic therapy (LST) compared with only ST in unresectable iCCA by performing a systematic literature review and meta-analysis. Methods: A comprehensive search comparing LSTs and STs for unresectable iCCA was performed in PubMed, Web of Science, EMBASE, and the Cochrane Library up to November 3, 2022. The primary outcome was overall survival (OS), and the secondary outcomes were progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). Results: Ten cohort studies with 3,791 unresectable iCCA patients were enrolled in this study, including 1,120 who received ablation, arterially directed therapy (ADT), or radiotherapy (RT) combined with ST. The meta-analysis showed that the LST group had a longer OS ( HR = 0.51; 95% CI = 0.41–0.64; p value &lt; 0.001) and PFS ( HR = 0.40, 95% CI = 0.22–0.71, p value = 0.002) and a better ORR ( RR = 1.68; 95% CI = 1.17–2.42; p value = 0.005). Subgroup analysis based on the type of locoregional treatment showed that both ST combined with ADT ( HR = 0.42, 95% CI = 0.31–0.56, p value &lt; 0.001) and RT ( HR = 0.67, 95% CI = 0.63–0.72, p value &lt; 0.001) could prolong OS. Combination with locoregional treatment does not result in additional severe AEs. Conclusions: Compared with only ST, LST improved survival outcomes for unresectable iCCA patients without increasing severe AEs, which can further provide a basis for guidelines.